Vid Desai FDA’s Chief Information Officer | Official Website
Vid Desai FDA’s Chief Information Officer | Official Website
This is a 44.5% decrease from the number of companies cited in the previous year.
Of the 308 citations issued, the most common citation was 'You did not develop an FSVP'.
Most of the companies cited were involved in the Food and Cosmetics sector. The second most common type of company cited in the time period worked in the the Devices sector.
Of the companies cited, 75 should take voluntary actions to correct their managing operations (92.6%). Additionally, six companies had to take regulatory and/or administrative actions (7.4%).
The FDA routinely inspects facilities across the nation to determine if the workplace and their products are compliant with FDA-regulated laws and regulations implemented to improve overall public health. Inspection results are then disclosed publicly.
The FDA is a government agency that is primarily responsible for monitoring the production and distribution of human and animal drugs, biological products, medical supplies and tobacco products for safety quality, according to its website.
Companies Located Within Miami-Dade County Cities and the Citations They Received in 2023
| Company Name | Area of Business | Inspection Date | Issue Cited |
|---|---|---|---|
| Advanced Instrumentations, Inc. | Devices | 03/10/2023 | Equipment control activity documentation |
| Advanced Instrumentations, Inc. | Devices | 03/10/2023 | Product rework procedures, Lack of or inadequate procedures |
| Advanced Instrumentations, Inc. | Devices | 03/10/2023 | Lack of or inadequate procedures |
| Advanced Instrumentations, Inc. | Devices | 03/10/2023 | Complaints |
| American Medical Endoscopy, Inc. | Devices | 10/11/2023 | Lack of Written MDR Procedures |
| Antonio E. Blanco, M.D. | Drugs | 01/30/2023 | FD-1572, protocol compliance |
| Antonio E. Blanco, M.D. | Drugs | 01/30/2023 | Case history records- inadequate or inadequate |
| Aztlan Foods, Corporation | Food and Cosmetics | 11/28/2023 | Sanitation preventive controls - Appropriate (Adequate) |
| Aztlan Foods, Corporation | Food and Cosmetics | 11/28/2023 | Supply-chain program - Establish |
| Beauty & Spa Concepts | Food and Cosmetics | 04/05/2023 | Equipment - procedures |
| Beauty & Spa Concepts | Food and Cosmetics | 04/05/2023 | Specifications - manufacturing process |
| Beauty & Spa Concepts | Food and Cosmetics | 04/05/2023 | Specifications - component identity |
| Beauty & Spa Concepts | Food and Cosmetics | 04/05/2023 | Specifications-component purity, strength, composition |
| Beauty & Spa Concepts | Food and Cosmetics | 04/05/2023 | Specifications - contamination limits |
| Beauty & Spa Concepts | Food and Cosmetics | 04/05/2023 | Specifications - labels, packaging |
| Beauty & Spa Concepts | Food and Cosmetics | 04/05/2023 | Specifications - contamination limits |
| Beauty & Spa Concepts | Food and Cosmetics | 04/05/2023 | Specifications - identity, purity, strength, composition |
| Beauty & Spa Concepts | Food and Cosmetics | 04/05/2023 | Reserve sample - collect, hold |
| Beauty & Spa Concepts | Food and Cosmetics | 04/05/2023 | Records - quality control operations; responsibilities |
| Beauty & Spa Concepts | Food and Cosmetics | 04/05/2023 | Written procedures - components |
| Beauty & Spa Concepts | Food and Cosmetics | 04/05/2023 | Written procedures - labels |
| Beauty & Spa Concepts | Food and Cosmetics | 04/05/2023 | Written procedures - packaging |
| Beauty & Spa Concepts | Food and Cosmetics | 04/05/2023 | Written procedures - rejected components, packaging, labels |
| Beauty & Spa Concepts | Food and Cosmetics | 04/05/2023 | Master manufacturing record - unique formulation |
| Beauty & Spa Concepts | Food and Cosmetics | 04/05/2023 | Batch record - every batch |
| Beauty & Spa Concepts | Food and Cosmetics | 04/05/2023 | Batch-lot,control number packaged, labeled dietary supplemen |
| Beauty & Spa Concepts | Food and Cosmetics | 04/05/2023 | Records - packaging, labeling operations |
| Beauty & Spa Concepts | Food and Cosmetics | 04/05/2023 | Records - returned dietary supplement: written procedures |
| Beauty & Spa Concepts | Food and Cosmetics | 04/05/2023 | Written procedures - product complaint; review, investigate |
| Beauty & Spa Concepts | Food and Cosmetics | 04/05/2023 | Records - available; FDA |
| Beauty & Spa Concepts | Food and Cosmetics | 04/05/2023 | Tests, examinations - scientifically valid |
| Benard Industries, Inc. | Food and Cosmetics | 02/01/2023 | Written procedures - quality control operations |
| Benard Industries, Inc. | Food and Cosmetics | 02/01/2023 | Written procedures - product complaint |
| Beraca Vally, Corp. | Food and Cosmetics | 01/17/2023 | Develop FSVP |
| Best Image Optical, Inc. | Devices | 03/09/2023 | Lack of Written MDR Procedures |
| Best Image Optical, Inc. | Devices | 03/09/2023 | Management review - Lack of or inadequate procedures |
| Best Image Optical, Inc. | Devices | 03/09/2023 | Quality audits - Lack of or inadequate procedures |
| Best Image Optical, Inc. | Devices | 03/09/2023 | Purchasing controls, Lack of or inadequate procedures |
| Best Image Optical, Inc. | Devices | 03/09/2023 | Lack of or inadequate receiving acceptance procedures |
| Best Image Optical, Inc. | Devices | 03/09/2023 | Lack of or inadequate procedures |
| Best Image Optical, Inc. | Devices | 03/09/2023 | Lack of or inadequate DHR procedures |
| Best Image Optical, Inc. | Devices | 03/09/2023 | Lack of or inadequate complaint procedures |
| Boston Nutraceutical Science, LLC | Food and Cosmetics | 05/02/2023 | Identification - entry |
| CFS Dental, Inc. | Devices | 10/31/2023 | Evaluation and Selection, Suppliers, Contractors, etc. |
| CNB Quality Food, Corp. | Food and Cosmetics | 06/13/2023 | Personnel |
| CNB Quality Food, Corp. | Food and Cosmetics | 06/13/2023 | Sanitary operations - Plant sanitation |
| CNB Quality Food, Corp. | Food and Cosmetics | 06/13/2023 | Equipment and utensils - Design and maintenance |
| Caribbean Gold | Food and Cosmetics | 06/05/2023 | Develop FSVP |
| Casmol, LLC | Food and Cosmetics | 10/10/2023 | Plant construction and design |
| Casmol, LLC | Food and Cosmetics | 10/10/2023 | Sanitation of food-contact surfaces - Frequency |
| Casmol, LLC | Food and Cosmetics | 10/10/2023 | Sanitation of non-food-contact surfaces - Manner and frequency |
| Casmol, LLC | Food and Cosmetics | 10/10/2023 | Sanitary facilities and controls |
| Casmol, LLC | Food and Cosmetics | 10/10/2023 | Equipment and utensils - Design and maintenance |
| Century Farms International | Food and Cosmetics | 12/08/2023 | Develop FSVP |
| Charanga Catering, LLC | Food and Cosmetics | 05/01/2023 | Qualifications of individuals |
| Charanga Catering, LLC | Food and Cosmetics | 05/01/2023 | Personnel |
| Charanga Catering, LLC | Food and Cosmetics | 05/01/2023 | Plant construction and design |
| Charanga Catering, LLC | Food and Cosmetics | 05/01/2023 | Sanitary operations - Plant sanitation |
| Charanga Catering, LLC | Food and Cosmetics | 05/01/2023 | Pest control |
| Charanga Catering, LLC | Food and Cosmetics | 05/01/2023 | Sanitary facilities and controls |
| Charanga Catering, LLC | Food and Cosmetics | 05/01/2023 | Equipment and utensils - Design and maintenance |
| Charanga Catering, LLC | Food and Cosmetics | 05/01/2023 | Manufacturing, processing, packing, holding - Controls |
| Chicago Produce, Inc. | Food and Cosmetics | 02/24/2023 | Develop FSVP |
| Chuck Enterprise, Inc. | Food and Cosmetics | 04/18/2023 | Develop FSVP |
| Chuck Enterprise, Inc. | Food and Cosmetics | 04/18/2023 | Evaluation - performance, risk |
| Chuck Enterprise, Inc. | Food and Cosmetics | 04/18/2023 | Supplier approval - document |
| Chuck Enterprise, Inc. | Food and Cosmetics | 04/18/2023 | Approved supplier procedures - importer established |
| Dalex Enterprises, Inc. | Food and Cosmetics | 05/26/2023 | Qualifications of individuals |
| Dalex Enterprises, Inc. | Food and Cosmetics | 05/26/2023 | Personnel |
| Dalex Enterprises, Inc. | Food and Cosmetics | 05/26/2023 | Plant construction and design |
| Dalex Enterprises, Inc. | Food and Cosmetics | 05/26/2023 | Sanitary operations - Plant sanitation |
| Dalex Enterprises, Inc. | Food and Cosmetics | 05/26/2023 | Toxic chemicals - Identified, held, stored |
| Dalex Enterprises, Inc. | Food and Cosmetics | 05/26/2023 | Pest control |
| Dalex Enterprises, Inc. | Food and Cosmetics | 05/26/2023 | Sanitation of food-contact surfaces - Frequency |
| Dalex Enterprises, Inc. | Food and Cosmetics | 05/26/2023 | Sanitary facilities and controls |
| Dalex Enterprises, Inc. | Food and Cosmetics | 05/26/2023 | Equipment and utensils - Design and maintenance |
| Dextrum Laboratories, Inc. | Drugs | 07/18/2023 | Exhaust systems inadequate to control air contamination |
| Dextrum Laboratories, Inc. | Drugs | 07/18/2023 | Reports of Analysis (Components) |
| Dextrum Laboratories, Inc. | Drugs | 07/18/2023 | Control procedures to monitor and validate performance |
| Dextrum Laboratories, Inc. | Drugs | 07/18/2023 | Representative Number of Batches for Annual Review |
| Dextrum Laboratories, Inc. | Drugs | 07/18/2023 | Complete instructions, procedures, specifications et. al. |
| Disjobel USA, LLC | Food and Cosmetics | 01/05/2023 | Hazard analysis written |
| Disjobel USA, LLC | Food and Cosmetics | 01/05/2023 | Hazard analysis biological, chemical, physical |
| Disjobel USA, LLC | Food and Cosmetics | 01/05/2023 | Supplier verification assurance |
| Disjobel USA, LLC | Food and Cosmetics | 01/05/2023 | Record - translate to English |
| EDT USA Corporation | Food and Cosmetics | 08/28/2023 | Develop FSVP |
| EDT USA Corporation | Food and Cosmetics | 08/28/2023 | Hazard analysis written |
| EDT USA Corporation | Food and Cosmetics | 08/28/2023 | Supplier approval - document |
| EDT USA Corporation | Food and Cosmetics | 08/28/2023 | Reevaluate - 3 years |
| EDT USA Corporation | Food and Cosmetics | 08/28/2023 | Supplier verification - establish written procedures |
| EDT USA Corporation | Food and Cosmetics | 08/28/2023 | Audit - food safety regulation, plan |
| Eco Produce, Inc. | Food and Cosmetics | 07/14/2023 | Develop FSVP |
| Exotic growers, Inc. | Food and Cosmetics | 03/28/2023 | Develop FSVP |
| Florida Smoked Fish, LLC | Food and Cosmetics | 10/18/2023 | HACCP plan implementation |
| Florida Smoked Fish, LLC | Food and Cosmetics | 10/18/2023 | Critical limits |
| Florida Smoked Fish, LLC | Food and Cosmetics | 10/18/2023 | Monitoring - adequacy |
| Florida Smoked Fish, LLC | Food and Cosmetics | 10/18/2023 | Corrective action plan |
| Florida Smoked Fish, LLC | Food and Cosmetics | 10/18/2023 | Sanitation monitoring |
| Gen Foods, Inc. | Food and Cosmetics | 08/17/2023 | Sanitary operations - Plant maintenance |
| Gen Foods, Inc. | Food and Cosmetics | 08/17/2023 | Storage and Distribution |
| Giuliana Produce, LLC | Food and Cosmetics | 03/24/2023 | Develop FSVP |
| GlobeSource Consumer Products, Inc. | Food and Cosmetics | 04/13/2023 | Develop FSVP |
| GlobeSource Consumer Products, Inc. | Food and Cosmetics | 04/13/2023 | LACF compliance |
| GlobeSource Consumer Products, Inc. | Food and Cosmetics | 04/13/2023 | Hazard analysis written |
| GlobeSource Consumer Products, Inc. | Food and Cosmetics | 04/13/2023 | Evaluation - performance, risk |
| GlobeSource Consumer Products, Inc. | Food and Cosmetics | 04/13/2023 | Approved supplier procedures - importer established |
| GlobeSource Consumer Products, Inc. | Food and Cosmetics | 04/13/2023 | Supplier verification - establish written procedures |
| Gonzalez and Nietos, LLC | Food and Cosmetics | 05/15/2023 | Develop FSVP |
| Gonzalez and Nietos, LLC | Food and Cosmetics | 05/15/2023 | Hazard analysis written |
| Gonzalez and Nietos, LLC | Food and Cosmetics | 05/15/2023 | Evaluation - performance, risk |
| Gonzalez and Nietos, LLC | Food and Cosmetics | 05/15/2023 | Evaluation - performance, risk |
| Gonzalez and Nietos, LLC | Food and Cosmetics | 05/15/2023 | Approved supplier procedures - importer established |
| Gonzalez and Nietos, LLC | Food and Cosmetics | 05/15/2023 | Supplier verification - establish written procedures |
| Gonzalez and Nietos, LLC | Food and Cosmetics | 05/15/2023 | Verification activity assurance |
| Gonzalez and Nietos, LLC | Food and Cosmetics | 05/15/2023 | Verification activity before import, periodically |
| Haribo Food 2004, Inc. | Food and Cosmetics | 03/22/2023 | Hazard analysis written |
| Haribo Food 2004, Inc. | Food and Cosmetics | 03/22/2023 | Evaluation - performance, risk |
| Haribo Food 2004, Inc. | Food and Cosmetics | 03/22/2023 | Verification activity frequency |
| Haribo Food 2004, Inc. | Food and Cosmetics | 03/22/2023 | Record - translate to English |
| Healthtex Distributors, Inc. | Food and Cosmetics | 12/01/2023 | Personnel - quality control operations; responsibilities |
| Healthtex Distributors, Inc. | Food and Cosmetics | 12/01/2023 | Written procedure quality control operations material review |
| Healthtex Distributors, Inc. | Food and Cosmetics | 12/01/2023 | Written procedures - holding |
| Healthtex Distributors, Inc. | Food and Cosmetics | 02/01/2023 | Quality control - quality, dietary supplement |
| Healthtex Distributors, Inc. | Food and Cosmetics | 02/01/2023 | Specifications - labels, packaging |
| Healthtex Distributors, Inc. | Food and Cosmetics | 02/01/2023 | Written procedures - holding; distributing |
| Healthtex Distributors, Inc. | Food and Cosmetics | 02/01/2023 | Records - returned dietary supplement: written procedures |
| IL Nuts | Food and Cosmetics | 09/28/2023 | Personnel |
| IL Nuts | Food and Cosmetics | 09/28/2023 | Sanitary operations - Plant sanitation |
| Ingapan usa, LLC | Food and Cosmetics | 09/22/2023 | Pest control |
| Ingapan usa, LLC | Food and Cosmetics | 09/22/2023 | Storage and Distribution |
| Interfood Trading Group, Inc. | Food and Cosmetics | 07/20/2023 | Develop FSVP |
| J. Sanchez Produce | Food and Cosmetics | 03/14/2023 | Not registered |
| J. Sanchez Produce | Food and Cosmetics | 03/14/2023 | Develop FSVP |
| Kanes Grower, LLC | Food and Cosmetics | 07/17/2023 | Hazard analysis biological, chemical, physical |
| Kendall Juice Corporation | Food and Cosmetics | 08/18/2023 | Sanitation monitoring |
| Kendall Juice Corporation | Food and Cosmetics | 08/18/2023 | No HACCP plan |
| Kendall Juice Corporation | Food and Cosmetics | 08/18/2023 | Process controls - not exempt, single facility |
| LEASA Industries Company, Inc. | Food and Cosmetics | 09/29/2023 | Hygienic practices |
| LEASA Industries Company, Inc. | Food and Cosmetics | 09/29/2023 | Handling harvested produce |
| LEASA Industries Company, Inc. | Food and Cosmetics | 09/29/2023 | Equip & tools - cleanability |
| LEASA Industries Company, Inc. | Food and Cosmetics | 09/29/2023 | Pest exclusion from fully-enclosed buildings |
| LEASA Industries Company, Inc. | Food and Cosmetics | 09/29/2023 | Sampling plan |
| LEASA Industries Company, Inc. | Food and Cosmetics | 09/29/2023 | Method - listeria environment - sprouts |
| La Lechonera Products, Inc. | Food and Cosmetics | 01/18/2023 | Quality control procedures |
| La Lechonera Products, Inc. | Food and Cosmetics | 01/18/2023 | Code - required elements |
| La Lechonera Products, Inc. | Food and Cosmetics | 01/18/2023 | Sanitary operations - Plant sanitation |
| Latin Arrow Importers & Distribu | Food and Cosmetics | 05/15/2023 | Develop FSVP |
| Lummacups, LLC | Devices | 01/19/2023 | Management review - Lack of or inadequate procedures |
| Lummacups, LLC | Devices | 01/19/2023 | Quality audits - Lack of or inadequate procedures |
| Lummacups, LLC | Devices | 01/19/2023 | Design control - no procedures |
| Lummacups, LLC | Devices | 01/19/2023 | Purchasing controls, Lack of or inadequate procedures |
| Lummacups, LLC | Devices | 01/19/2023 | Lack of or inadequate procedures |
| Manuel F. Fernandez, M.D. | Drugs | 02/17/2023 | FD-1572, protocol compliance |
| Manzo Food Sales, Inc. | Food and Cosmetics | 08/15/2023 | Hazard analysis written |
| Manzo Food Sales, Inc. | Food and Cosmetics | 08/15/2023 | Hazard analysis biological, chemical, physical |
| Manzo Food Sales, Inc. | Food and Cosmetics | 08/15/2023 | Evaluation - performance, risk |
| Manzo Food Sales, Inc. | Food and Cosmetics | 08/15/2023 | Supplier approval - document |
| Manzo Food Sales, Inc. | Food and Cosmetics | 08/15/2023 | Reevaluate - 3 years |
| Manzo Food Sales, Inc. | Food and Cosmetics | 08/15/2023 | Approved supplier procedures - importer established |
| Manzo Food Sales, Inc. | Food and Cosmetics | 08/15/2023 | Verification activity frequency |
| Manzo Food Sales, Inc. | Food and Cosmetics | 08/15/2023 | Verification activity - appropriate |
| Manzo Food Sales, Inc. | Food and Cosmetics | 08/15/2023 | Verification activity before import, periodically |
| Manzo Food Sales, Inc. | Food and Cosmetics | 08/15/2023 | Record - available |
| Maria I. Bermudez, M.D. | Biologics | 06/28/2023 | FD-1572, protocol compliance |
| Marina Foods, Inc. | Food and Cosmetics | 07/27/2023 | Raw materials - Allergen identification |
| Marina Foods, Inc. | Food and Cosmetics | 07/27/2023 | Process preventive controls - Identify (Written) |
| Marina Foods, Inc. | Food and Cosmetics | 07/27/2023 | Sanitation preventive controls - Appropriate (Adequate) |
| Marina Foods, Inc. | Food and Cosmetics | 07/27/2023 | Allergen preventive controls - Implementation records |
| Marina Foods, Inc. | Food and Cosmetics | 07/27/2023 | Supply-chain program - Implement |
| Maxxion Technology, LLC | Devices | 06/08/2023 | Availability |
| Mayrsohn International Trading Company, Inc. | Food and Cosmetics | 03/13/2023 | Hazard analysis written |
| Mayrsohn International Trading Company, Inc. | Food and Cosmetics | 03/13/2023 | Document review entity's hazard analysis |
| Mayrsohn International Trading Company, Inc. | Food and Cosmetics | 03/13/2023 | Evaluation - performance, risk |
| Mayrsohn International Trading Company, Inc. | Food and Cosmetics | 03/13/2023 | Supplier approval - document |
| Mayrsohn International Trading Company, Inc. | Food and Cosmetics | 03/13/2023 | Reevaluate - 3 years |
| Mayrsohn International Trading Company, Inc. | Food and Cosmetics | 03/13/2023 | Evaluation, reevaluation - another entity |
| Mayrsohn International Trading Company, Inc. | Food and Cosmetics | 03/13/2023 | Evaluation, reevaluation - qualified individual |
| Mayrsohn International Trading Company, Inc. | Food and Cosmetics | 03/13/2023 | Approved supplier procedures - follow, document use |
| Mayrsohn International Trading Company, Inc. | Food and Cosmetics | 03/13/2023 | Unapproved supplier procedures - importer established |
| Mayrsohn International Trading Company, Inc. | Food and Cosmetics | 03/13/2023 | Supplier verification - establish written procedures |
| Mayrsohn International Trading Company, Inc. | Food and Cosmetics | 03/13/2023 | Verification activity assurance |
| Mayrsohn International Trading Company, Inc. | Food and Cosmetics | 03/13/2023 | Verification activity - appropriate |
| Mayrsohn International Trading Company, Inc. | Food and Cosmetics | 03/13/2023 | Verification activity - another entity, assess |
| Mayrsohn International Trading Company, Inc. | Food and Cosmetics | 03/13/2023 | Verification activity - another entity, qualified individual |
| Mayrsohn International Trading Company, Inc. | Food and Cosmetics | 03/13/2023 | Verification activity before import, periodically |
| McArthur Next, LLC | Food and Cosmetics | 03/17/2023 | Verification activities - minimum |
| McArthur Next, LLC | Food and Cosmetics | 03/17/2023 | Calibration, testing - no records |
| Medina Baking and Powder Products, Inc. | Food and Cosmetics | 07/13/2023 | Pest control |
| Naked International, Inc. | Devices | 09/26/2023 | Design history file |
| Naked International, Inc. | Devices | 09/26/2023 | Evaluation of suppliers, contractors, etc., requirements |
| Naked International, Inc. | Devices | 09/26/2023 | Documentation |
| Naked International, Inc. | Devices | 09/26/2023 | Complaints |
| Natural Ginger, Corporation | Food and Cosmetics | 12/22/2023 | Component - verify identity, dietary ingredient |
| Natural Ginger, Corporation | Food and Cosmetics | 12/22/2023 | Component - qualify supplier |
| Natural Ginger, Corporation | Food and Cosmetics | 12/22/2023 | Written procedures - quality control operations |
| Natural Ginger, Corporation | Food and Cosmetics | 12/22/2023 | Master manufacturing record - unique formulation |
| Natural Ginger, Corporation | Food and Cosmetics | 12/22/2023 | Batch record - every batch |
| Natural Ginger, Corporation | Food and Cosmetics | 12/22/2023 | Written procedures - holding |
| Natural Ginger, Corporation | Food and Cosmetics | 12/22/2023 | Records - returned dietary supplement: written procedures |
| Natural Ginger, Corporation | Food and Cosmetics | 12/22/2023 | Written procedures - product complaint; review, investigate |
| Natural Vitamins Laboratory Corporation | Food and Cosmetics | 06/20/2023 | Specifications - manufacturing process |
| Natural Vitamins Laboratory Corporation | Food and Cosmetics | 06/20/2023 | Specifications - identity, purity, strength, composition |
| Natural Vitamins Laboratory Corporation | Food and Cosmetics | 06/20/2023 | Component - qualify supplier |
| Natural Vitamins Laboratory Corporation | Food and Cosmetics | 06/20/2023 | Master manufacturing record - each batch |
| Natural Vitamins Laboratory Corporation | Food and Cosmetics | 06/20/2023 | Batch record - every batch |
| Natural Vitamins Laboratory Corporation | Food and Cosmetics | 06/20/2023 | Laboratory control processes - requirements |
| Natural Vitamins Laboratory Corporation | Food and Cosmetics | 06/20/2023 | Examination, testing; scientifically valid |
| Natural Vitamins Laboratory Corporation | Food and Cosmetics | 06/20/2023 | Quality control - ensure quality; package, labeled, master record |
| Naturavit, Inc. | Food and Cosmetics | 07/19/2023 | Specifications - identity, purity, strength, composition |
| Naturavit, Inc. | Food and Cosmetics | 07/19/2023 | Appropriate tests, examinations; certificate of analysis |
| Naturavit, Inc. | Food and Cosmetics | 07/19/2023 | Quality control - packaged, labeled |
| Naturavit, Inc. | Food and Cosmetics | 07/19/2023 | Quality control operations - labeling; quarantine |
| Naturavit, Inc. | Food and Cosmetics | 07/19/2023 | Written procedures - labeling operations |
| New Limeco, LLC | Food and Cosmetics | 08/21/2023 | Hazard analysis written |
| New Limeco, LLC | Food and Cosmetics | 08/21/2023 | Evaluation - performance, risk |
| New Limeco, LLC | Food and Cosmetics | 08/21/2023 | Approved supplier procedures - follow, document use |
| New Limeco, LLC | Food and Cosmetics | 08/21/2023 | Verification activity - appropriate |
| New Limeco, LLC | Food and Cosmetics | 08/21/2023 | Verification activity before import, periodically |
| New York Bakeries, Inc. | Food and Cosmetics | 03/27/2023 | Qualifications of individuals |
| New York Bakeries, Inc. | Food and Cosmetics | 03/27/2023 | Personnel |
| New York Bakeries, Inc. | Food and Cosmetics | 03/27/2023 | Plant construction and design |
| New York Bakeries, Inc. | Food and Cosmetics | 03/27/2023 | Pest control |
| New York Bakeries, Inc. | Food and Cosmetics | 03/27/2023 | Sanitation of food-contact surfaces - Frequency |
| New York Bakeries, Inc. | Food and Cosmetics | 03/27/2023 | Manufacturing, processing, packing, holding - Controls |
| Ocho Rios-Miami, Inc. | Food and Cosmetics | 07/17/2023 | Hazard analysis |
| Ocho Rios-Miami, Inc. | Food and Cosmetics | 07/17/2023 | HACCP plan implementation |
| Ocho Rios-Miami, Inc. | Food and Cosmetics | 07/17/2023 | Food safety hazards |
| Ocho Rios-Miami, Inc. | Food and Cosmetics | 07/17/2023 | Verification - record review - frequency |
| Ocho Rios-Miami, Inc. | Food and Cosmetics | 07/17/2023 | Verification - recordkeeping |
| Olga's Sons Distributors | Food and Cosmetics | 04/07/2023 | Develop FSVP |
| Osteolife Biomedical I, LLC | Biologics | 02/14/2023 | Validation & approval--established procedures |
| Pharma-Natural, Inc. | Food and Cosmetics | 06/23/2023 | Personnel - hygienic practices |
| Pharma-Natural, Inc. | Food and Cosmetics | 06/23/2023 | Water supply - may be component - suitability |
| Pharma-Natural, Inc. | Food and Cosmetics | 06/23/2023 | Specifications - manufacturing process |
| Pharma-Natural, Inc. | Food and Cosmetics | 06/23/2023 | Specifications met, in-process - quality finished batch |
| Pharma-Natural, Inc. | Food and Cosmetics | 06/23/2023 | Specifications met - verify; finished batch |
| Pharma-Natural, Inc. | Food and Cosmetics | 06/23/2023 | Scheduled process establishment |
| Premier Distributors Of Miami Corporation | Food and Cosmetics | 02/10/2023 | Process filing |
| Premier Distributors Of Miami Corporation | Food and Cosmetics | 02/10/2023 | Quality control procedures |
| Premier Distributors Of Miami Corporation | Food and Cosmetics | 02/10/2023 | Raw materials, packaging, finished product |
| Premier Distributors Of Miami Corporation | Food and Cosmetics | 02/10/2023 | Plant construction and design |
| Prime Matter Labs | Drugs | 09/01/2023 | Buildings not maintained in good state of repair |
| Prime Matter Labs | Drugs | 09/01/2023 | Absence of Written Procedures |
| Prime Matter Labs | Drugs | 09/01/2023 | Reprocessing/quality control unit |
| Prime Matter Labs | Drugs | 09/01/2023 | Scientifically sound laboratory controls |
| Prime Matter Labs | Drugs | 09/01/2023 | No written record of investigation |
| Prime Matter Labs | Veterinary | 09/01/2023 | Buildings not maintained in good state of repair |
| Prime Matter Labs | Veterinary | 09/01/2023 | Absence of Written Procedures |
| Prime Matter Labs | Veterinary | 09/01/2023 | Reprocessing/quality control unit |
| Prime Matter Labs | Veterinary | 09/01/2023 | Scientifically sound laboratory controls |
| Prime Matter Labs | Veterinary | 09/01/2023 | No written record of investigation |
| Pure Source, LLC | Devices | 08/31/2023 | Documented evaluation |
| Rika Bakeries, Inc. | Food and Cosmetics | 02/14/2023 | Personnel |
| Rika Bakeries, Inc. | Food and Cosmetics | 02/14/2023 | Sanitary operations - Plant maintenance |
| Rika Bakeries, Inc. | Food and Cosmetics | 02/14/2023 | Sanitary facilities and controls |
| Rosa M. Suarez, M.D. | Biologics | 03/10/2023 | Circumstances of obtaining consent |
| Rosa M. Suarez, M.D. | Biologics | 03/10/2023 | FD-1572, protocol compliance |
| Rosa M. Suarez, M.D. | Biologics | 03/10/2023 | Case history records- inadequate or inadequate |
| Rosa M. Suarez, M.D. | Drugs | 03/10/2023 | Circumstances of obtaining consent |
| Rosa M. Suarez, M.D. | Drugs | 03/10/2023 | FD-1572, protocol compliance |
| Rosa M. Suarez, M.D. | Drugs | 03/10/2023 | Case history records- inadequate or inadequate |
| S. O. S. Food Lab, LLC | Food and Cosmetics | 06/16/2023 | Personnel |
| S. O. S. Food Lab, LLC | Food and Cosmetics | 06/16/2023 | Bottling room separation, plant operations |
| S. O. S. Food Lab, LLC | Food and Cosmetics | 06/16/2023 | Bacteriological swab, rinse count - containers, closures (S) |
| S. O. S. Food Lab, LLC | Food and Cosmetics | 06/16/2023 | Bacteriological test - bottled water |
| S. O. S. Food Lab, LLC | Food and Cosmetics | 06/16/2023 | Chemical, physical, radiological tests - bottled water |
| San Jose Trading, Corp. | Food and Cosmetics | 02/24/2023 | Evaluation - performance, risk |
| San Jose Trading, Corp. | Food and Cosmetics | 02/24/2023 | Onsite audit |
| San Jose Trading, Corp. | Food and Cosmetics | 02/24/2023 | Record - translate to English |
| Scientific Supplies & Technology, Inc. | Devices | 11/09/2023 | Lack of Written MDR Procedures |
| Scientific Supplies & Technology, Inc. | Devices | 11/09/2023 | Lack of or inadequate procedures |
| Scientific Supplies & Technology, Inc. | Devices | 11/09/2023 | DHR - not or inadequately maintained |
| Scientific Supplies & Technology, Inc. | Devices | 11/09/2023 | Lack of or inadequate complaint procedures |
| Silq Technologies Corporation | Devices | 01/05/2023 | Management review - defined interval, sufficient frequency |
| Silq Technologies Corporation | Devices | 01/05/2023 | Lack of or inadequate complaint procedures |
| Sula Food and Beverage Corporation | Food and Cosmetics | 01/23/2023 | Develop FSVP |
| Sunsof, Inc. | Food and Cosmetics | 12/14/2023 | Hazard analysis - Identification of hazard |
| Tasa USA, Inc. | Food and Cosmetics | 02/23/2023 | Hazard analysis written |
| Tasa USA, Inc. | Food and Cosmetics | 02/23/2023 | Evaluation - performance, risk |
| Tasa USA, Inc. | Food and Cosmetics | 02/23/2023 | Reevaluate - 3 years |
| Tasa USA, Inc. | Food and Cosmetics | 02/23/2023 | Approved supplier procedures - importer established |
| Tasa USA, Inc. | Food and Cosmetics | 02/23/2023 | Supplier verification - establish written procedures |
| Tasa USA, Inc. | Food and Cosmetics | 02/23/2023 | Verification activity frequency |
| Tasa USA, Inc. | Food and Cosmetics | 02/23/2023 | Verification activity - appropriate |
| Tasa USA, Inc. | Food and Cosmetics | 02/23/2023 | Verification activity before import, periodically |
| The Green Fruit Company, LLC | Food and Cosmetics | 11/03/2023 | Develop FSVP |
| Toby Orthopaedics, Inc. | Devices | 04/28/2023 | Management review - defined interval, sufficient frequency |
| Toby Orthopaedics, Inc. | Devices | 04/28/2023 | Design validation - documentation |
| Toby Orthopaedics, Inc. | Devices | 04/28/2023 | Design transfer - Lack of or inadequate procedures |
| Toby Orthopaedics, Inc. | Devices | 04/28/2023 | Records of complaint investigation |
| Tory P. Sullivan, P. A., M.D. | Drugs | 03/03/2023 | FD-1572, protocol compliance |
| Tory P. Sullivan, P. A., M.D. | Drugs | 03/03/2023 | Case history records- inadequate or inadequate |
| Tropical Bakery Wholesale Corporation | Food and Cosmetics | 05/19/2023 | Supply-chain program - Implement |
| Txapela | Food and Cosmetics | 03/02/2023 | Develop FSVP |
| US Infusion, Inc. | Devices | 03/06/2023 | Evaluation of suppliers, contractors, etc., requirements |
| US Infusion, Inc. | Devices | 03/06/2023 | Documentation |
| USpharma, Ltd. | Devices | 05/11/2023 | Report of Death or Serious Injury |
| Ultra Orange, LLC | Food and Cosmetics | 09/05/2023 | Develop FSVP |
| Umay Trade Company, LLC | Veterinary | 06/16/2023 | Evaluation - performance, risk |
| Umay Trade Company, LLC | Veterinary | 06/16/2023 | Supplier approval - document |
| Umay Trade Company, LLC | Veterinary | 06/16/2023 | Approved supplier procedures - importer established |
| Umay Trade Company, LLC | Veterinary | 06/16/2023 | Verification activity assurance |
| Valdes Farm, Inc. | Food and Cosmetics | 12/08/2023 | Hazard analysis written |
| Valdes Farm, Inc. | Food and Cosmetics | 12/08/2023 | Supplier approval - document |
| Valdes Farm, Inc. | Food and Cosmetics | 12/08/2023 | Supplier verification - establish written procedures |
| Valdes Farm, Inc. | Food and Cosmetics | 12/08/2023 | Verification activity frequency |
| Valdes Farm, Inc. | Food and Cosmetics | 12/08/2023 | Verification activity before import, periodically |
| Xel-Ha, LLC | Food and Cosmetics | 08/31/2023 | Develop FSVP |
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